Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale

Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene lastnosti (IEC 60601-1:2005/AMD1:2012)

General Information

Status
Published
Publication Date
21-Jul-2014
ICS
11.040 - Medical equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
CLC/TC 62 - Electrical equipment in medical practice
Current Stage
6060 - Document made available - Publishing
Start Date
22-Jul-2014
Completion Date
22-Jul-2014
Directive
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Ref Project
SIST EN 60601-1:2007/A1:2014/AC:2015 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Relations

Corrects
EN 60601-1:2006/A1:2013 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Effective Date
23-Jan-2023
EN 60601-1:2007/A1:2014/AC:2015 - Page 3 previewEN 60601-1:2007/A1:2014/AC:2015 - Page 1 previewEN 60601-1:2007/A1:2014/AC:2015 - Page 2 previewEN 60601-1:2007/A1:2014/AC:2015 - Page 4 preview
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Corrigendum

EN 60601-1:2007/A1:2014/AC:2015

English language
1 pages
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Frequently Asked Questions

EN 60601-1:2006/A1:2013/AC:2014 is a corrigendum published by CLC. Its full title is "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This standard covers: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

EN 60601-1:2006/A1:2013/AC:2014 is classified under the following ICS (International Classification for Standards) categories: 11.040 - Medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 60601-1:2006/A1:2013/AC:2014 has the following relationships with other standards: It is inter standard links to EN 60601-1:2006/A1:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-1:2006/A1:2013/AC:2014 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/295, M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase EN 60601-1:2006/A1:2013/AC:2014 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.

Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen LeistungsmerkmaleAppareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentiellesMedical electrical equipment - Part 1: General requirements for basic safety and essential performance11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 60601-1:2006/A1:2013/AC:2014SIST EN 60601-1:2007/A1:2014/AC:2015en,fr,de01-maj-2015SIST EN 60601-1:2007/A1:2014/AC:2015SLOVENSKI
STANDARD
July 2014 IEC 60601-1:2005/AMD1:2012 (Amendment 1 to the third edition)
Medical electrical equipment – Part 1: General requirements for bas
...

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기사 제목: EN 60601-1:2006/A1:2013/AC:2014 - 의료 전기 장치 - 제1부: 기본 안전 및 필수 성능에 대한 일반 요구 사항 기사 내용: 이 기사는 의료 전기 장치의 기본 안전 및 필수 성능에 대한 일반 요구 사항을 다루는 EN 60601-1:2006/A1:2013/AC:2014 표준에 관한 것입니다. 이 표준은 의료 전기 장치의 설계, 제조 및 테스트에 대한 지침을 제공하여 안전성과 효과를 보장합니다. 또한, 위험 관리, 전기 절연, 온도 및 기계 강도에 대한 규정도 포함되어 있습니다. 이 표준은 주기적으로 개정되어 기술의 발전에 발맞추고 환자와 의료 전문가들을 위한 최고 수준의 안전을 보장합니다.

The article discusses the EN 60601-1:2006/A1:2013/AC:2014 standard, which pertains to general requirements for basic safety and essential performance in medical electrical equipment. The standard provides guidelines for the design, manufacturing, and testing of these devices to ensure their safety and effectiveness. It also includes provisions for risk management, electrical insulation, temperature, and mechanical strength. The standard is revised periodically to keep up with advances in technology and ensure the highest level of safety for patients and healthcare professionals.

記事のタイトル: EN 60601-1:2006/A1:2013/AC:2014 - 医療電気機器 - 第1部: 基本的な安全性と必要性のための一般的要件 記事の内容: この記事では、医療電気機器の基本的な安全性と必要性のための一般的要件に関するEN 60601-1:2006/A1:2013/AC:2014規格について説明されています。この規格は、これらのデバイスの設計、製造、テストに関するガイドラインを提供し、その安全性と効果を確保します。また、リスクマネジメント、電気絶縁、温度、機械的強度に関する規定も含まれています。この規格は、技術の進歩に対応し、患者や医療専門家の最高水準の安全性を確保するために定期的に改訂されています。